Italian CDMO buys India API plant that supplies Novartis

CDMO Olon is continuing its expansion binge with a deal to buy an API plant in India that supplies ingredients to Novartis.

The Italian generic drug and API maker said Tuesday that it is buying an API manufacturing facility in Mahad, India, that supplies ingredients to Sandoz, the generics division of Novartis. Olon said that as part of the purchase agreement, it has committed to a long-term supply contract to supply the Sandoz products manufactured in Mahad. Sandoz closed a plant in Mahad in 2016.

It said no jobs would be lost and that Olon intends to invest in the site, which also provides drugs to the Indian healthcare system. Terms of the deal were not disclosed.

“By acquiring a manufacturing base in India, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to develop new generic products for the Indian market,” Olon CEO Paolo Tubertini said in a statement. “It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements. (cr: FiercePharma)



India’s drug regulatory force conducts third round of raids on manufacturers

India’s drug regulatory force, the Central Drugs Standards Control Organization, pulled off a third round of raids on drug facilities that were manufacturing products without approval. In the latest round of raids, the agency focused on manufacturing firms in Sikkim that resulted in the cancellation of one license and suspension of another, The Wire reported. The raids last week, which come in the wake of similar actions in Uttarakhand and Daman, targeted drug manufacturing firms Savi Healthsciences and Savi Pharma.

The agency cancelled Savi Pharma’s license and ordered it to dispose of all processed tablets, capsules and sterile products.

In the case of the raid on Savi Healthsciences, inspectors found the firm was manufacturing drugs in areas of the plant that were under construction. The company was also cited for not keeping appropriate records of their manufacturing process.

India leads increasing antibiotic consumption

India’s total use of antibiotics more than doubled from 2000 to 2015, new research says, making the country the world’s biggest consumer of antibiotics and stoking fears of increasing antibiotic resistance.

When calculated as doses per 1,000 inhabitants per day, global antibiotic consumption rose 39%, with India increasing 63%, China increasing 65%, and Pakistan increasing 21%. In high-income countries, total consumption increased modestly while doses per 1,000 inhabitants per day fell 4%.

“Of particular concern was the rapid increase in the use of last-resort compounds” such as glycylcyclines, oxazolidinones, carbapenems, and polymyxins in all countries, the authors say. “Radical rethinking of policies to reduce consumption is necessary, including major investments in improved hygiene, sanitation, vaccination, and access to diagnostic tools both to prevent unnecessary antibiotic use and to decrease the burden of infectious disease.”

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Scientists at India’s government labs struggle to adjust to changing priorities

Government lab researchers in India are feeling pushed to abandon fundamental research projects in favor of more applied, mission-driven work.

The shift follows deep budget cuts at the Council of Scientific & Industrial Research (CSIR), India’s largest R&D organization. “The funding available this year is short by half of what is needed,” says Rakesh K. Mishra, director of India’s Centre for Cellular & Molecular Biology (CCMB), one of 38 CSIR labs across the country.

Frustrated and angry, many scientists hesitate to openly voice their concerns because they fear retaliation. “Many research projects have been affected. Projects cannot stop overnight, so we continue what we can with the reagents we have,” says a senior scientist from a New Delhi-based CSIR lab who asked to remain anonymous. “The institute is functioning at minimum running costs.”

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India’s government lab funding

Adjusting for inflation, CSIR will get a slight budget decrease under Prime Minister Modi’s proposed budget for the coming fiscal year.
a Numbers adjusted for inflation to 2018 rupees using the combined rural and urban CPI in January before the start of the fiscal year.
b Proposed; figure converted from Indian rupees to U.S. dollars at the March 7 exchange rate of $1.00 = 64.98 rupees.
Sources: CSIR, Ministry of Statistics & Programme Implementation.

India’s drug security threatened by reliance on imports

Concern is growing in India about pharmaceutical companies’ dependence on low-cost bulk drug imports from China to meet escalating demand for pharmaceuticals at home and for export.

Although India is a key supplier of formulated generic and affordable medicines to the world market, it imports bulk active pharmaceutical ingredients (APIs) from China, Germany, Italy, Singapore, and the U.S. China alone accounts for 66% of crucial raw materials, especially antibiotics.

Indian companies are capable of manufacturing the APIs in needed quantities, but the compounds can be imported at lower cost, India’s Minister of State for Chemicals & Fertilizers, Mansukh L. Mandaviya, told India’s Parliament on Dec. 19.

The Indian government had started in 2016 to develop API manufacturing parks with infrastructure such as better power supplies and waste treatment plants. That effort is currently in limbo as the government tries to figure out how to finance the projects.